Identity
- Trade Name
- HbA1c Reagent Kit FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, kit, spectrophotometry FDA UDI
- Device Name
- HbA1c Reagent Kit for use with EasyRA Analyzers FDA UDI
- Model / Reference
- 10230-2 FDA UDI
- Description
- HbA1c Reagent Kit for use with EasyRA Analyzers FDA UDI
Identifiers
- Catalog Number
- 10230-2 FDA UDI
- Primary DI / UDI-DI
- 00386100002268 FDA UDI
- 510(k) Number
- K120497 FDA UDI
- FDA Product Code
- LCP FDA UDI
- GMDN Term
- Glycated haemoglobin (HbA1c) IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7470 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Glycated haemoglobin (HbA1c) IVD, kit, spectrophotometry
HbA1c Reagent Kit by Medica Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glycated haemoglobin (HbA1c) IVD, kit, spectrophotometry.
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medica Corp.
Sources (1)
- FDA UDI 97dc7609-d424-48b8-9b3b-32e62e2a41ed 37 fields · synced May 30, 2026